Completed

A Phase I Randomized Dose/Formulation Comparison Study of SC-52151

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What is being tested

Telinavir

Drug
Who is being recruted

HIV Infections

Over 21 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
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PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151. SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and immunological and virological markers and toxicity. Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies. Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies. Patients are randomized to four treatment arms to receive SC-52151 elixir or SEDDS formulation at 1 of 2 doses for 2 weeks, with follow-up for 14 days.

Official TitleA Phase I Randomized Dose/Formulation Comparison Study of SC-52151 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
48 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria Concurrent Medication: Required for patients with CD4 count \<= 200 cells/mm3: * PCP prophylaxis using TMP/SMX or aerosolized pentamidine. Allowed: * Topical antifungal agents. * Up to 1000 mg/day acyclovir as maintenance therapy for herpes simplex virus. * Antibiotics for bacterial infections. * Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone for symptomatic treatment. Patients must have: * HIV infection. * CD4 count 150 - 500 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Unable to tolerate the standard diet required for the study. * Unable to give informed consent. Concurrent Medication: Excluded: * Antiretrovirals and biologic response modifiers (including HIV vaccines). * Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin. * Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis. * Allopurinol. * Omeprazole. * Astemizole. * Terfenadine. * Loratadine. * Psychotropics. * Phenylbutazone. * Barbiturates. * Benzodiazepines. * Monoamine oxidase inhibitors. * H-2 blockers. * Anticonvulsants. * Coumadin anticoagulants. * Oral contraceptives. * Antiarrhythmics. * Diltiazem. * Metronidazole. * Erythromycin. * Chloramphenicol. * Fluoroquinolones. * Disulfiram. * Erythropoietin. * G-CSF or GM-CSF. * Systemic corticosteroids. * Alcohol, including alcohol-containing medications. Patients with the following prior conditions are excluded: * Unexplained temperature \>= 38.5 C for any 7 days within the 30 days prior to study entry. * Chronic diarrhea (\>= three stools per day) for any 15 days within the 30 days prior to study entry. * Malignancy other than basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, and minimal Kaposi's sarcoma. Prior Medication: Excluded at any time: * Prior HIV protease inhibitor. Excluded within 30 days prior to study entry: * Investigational drugs. * Recombinant erythropoietin. * G-CSF or GM-CSF. * Interferon or interleukin. * Any HIV-1 vaccine. Excluded within 14 days prior to study entry: * Antiretrovirals. * Acute therapy for any opportunistic or other serious infection. * Therapy for malignancy. * Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin. * Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis. Excluded within 7 days prior to study entry: * Allopurinol. * Omeprazole. * Astemizole. * Terfenadine. * Loratadine. * Psychotropics. * Phenylbutazone. * Barbiturates. * Benzodiazepines. * Monoamine oxidase inhibitors. * H-2 blockers. * Anticonvulsants. * Coumadin anticoagulants. * Oral contraceptives. * Antiarrhythmics. * Diltiazem. * Metronidazole. * Erythromycin. * Chloramphenicol. * Fluoroquinolones. * Disulfiram. Risk Behavior: Excluded: * History of substance or alcohol abuse. * Ingestion of more than 50 g alcohol daily within 6 months prior to study entry. * Recovered alcoholic.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 4 locations
Suspended
Univ of California / San Diego Treatment CtrSan Diego, United StatesSee the location
Suspended
Univ of Miami School of MedicineMiami, United States
Suspended
Johns Hopkins HospBaltimore, United States
Suspended
Ohio State Univ Hosp ClinicColumbus, United States

Completed4 Study Centers